Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Iaso, Novo Nordisk, Scholar Rock, Vicore, Vyluma, Zhaoke.
In a devastating blow to the company and large B-cell lymphoma patients relapsed or refractory to CD19 CAR T-cell therapy, Cargo Therapeutics Inc. terminated the phase II study of its lead CD22 cell therapy, firicabtagene autoleucel (firi-cel), and is cutting its workforce by 50% and evaluating strategic options, following disappointing data on durability of response and serious safety events, some of which were fatal.
It’s one step backward in order to take two steps forward at Zentalis Pharmaceuticals Inc. In a restructuring to help fund the second part of its potentially registration-enabling Denali study, Zentalis has laid off 40% of its workforce. The clinical trial of azenosertib, Zentalis’ lead candidate and a WEE1 kinase inhibitor, is for treating advanced solid tumors and hematologic malignancies. The therapy is designed to make cancer cells self-destruct.
The final tally shows U.K. biotechs raised £3.5 billion (US$4.35 billion) in 2024, a stonking 93% more than in 2023, and surpassing the total in 2020, before the life sciences investment boom sparked by the pandemic. Of this, £2.1 billion was in venture capital, a 64.8% increase on 2023, while U.K biotechs attracted £1.5 billion in follow-on offerings, most of it raised by companies listed on Nasdaq.
Biopharma financings saw their third highest year, with companies collectively raising $102.15 billion in 2024, behind only 2020 and 2021. The amount marked a 44% jump from $70.97 billion in financings in 2023 and a 68% increase from $60.81 billion in 2022. The fourth quarter (Q4) contributed $15.45 billion, the lowest quarter of the year, following $16.38 billion in Q3, $23.07 billion in Q2, and a strong $47.25 billion in Q1.
President Donald Trump’s recently issued executive order (EO) putting a stop to diversity, equity, and inclusion programs in the U.S. government is sending ripples far and wide, into areas that some might not have anticipated. The FDA has taken down from its website the guidelines regarding action plans related to achieving diversity in clinical trials.
Implanted patches of iPS-derived heart muscle integrated with heart tissue in a primate model of heart failure, and in patients being treated in a clinical trial, marks progress toward a potential option for patients with advanced heart failure.
At his confirmation hearing, Robert F. Kennedy Jr., the nominee for secretary of the U.S. Department of Health and Human Services, claimed that he is not anti-vaccine. But his record does not bear that out. Kennedy is a longstanding vaccine denier, and in 2021 was identified as one of the “Disinformation Dozen” – the 12 accounts responsible for the majority of disinformation about COVID-19 vaccines on social media platforms – by the British-American nonprofit Center for Countering Digital Hate.
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